Overview:
We are seeking an experienced Manufacturing Execution System (MES) Engineer to join our team. This is a challenging opportunity to work in a biologics manufacturing environment, where you will be responsible for developing and maintaining MES recipes, specifications, and process logic.
Key Responsibilities:
* MES Development: Develop and maintain MES recipes, specifications, and process logic to ensure seamless execution.
* Process Validation: Validate and document new processes, identifying potential risks and implementing mitigations where necessary.
* Site Alignment: Align site procedures with MES workflows, ensuring efficient production operations.
* User Training: Train users on MES systems and manage access permissions to ensure data integrity.
* Troubleshooting: Support MES governance and troubleshoot system issues to minimize downtime.
Requirements:
* Bachelor's degree in engineering, manufacturing, business, or related field.
* At least 2 years' experience authoring in MES systems, preferably POMSnet.
* Strong understanding of MES configuration and interfaces, including SAP (MM, PP, IM).
* Experience working in FDA/HPRA-regulated batch manufacturing environments.
* Proficient knowledge of cGMP and pharma regulations.